Pain drugs' safety for heart patients doubted again

NEW YORK (Reuters Health) - Heart disease patients who chronically use painkillers like ibuprofen and naproxen might face an increased risk of suffering a heart attack or dying from cardiovascular causes, a new study suggests.

The findings, from a study of more than 22,000 heart disease patients with high blood pressure, add to concerns about the safety of most of the medications known as non-steroidal anti-inflammatory drugs, or NSAIDs.

Still, they don't necessarily mean the drugs themselves are to blame.

NSAIDs include over-the-counter painkillers such as aspirin, ibuprofen (Advil, Motrin and other brands) and naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors.

With the exception of aspirin, which is known to cut the risk of heart attack, the safety of NSAIDs for people with heart disease has long been in question.

It started with COX-2 inhibitors, which were linked to increased risks of heart attack and other cardiovascular problems. Two of the drugs -- rofecoxib (Vioxx) and valdecoxib (Bextra) -- were pulled from the market in 2004 and 2005; a third COX-2 inhibitor, celecoxib (Celebrex), remains on the market.

But research since then have also raised questions about over-the-counter NSAIDs other than aspirin.

In this latest study, researchers found that heart disease patients who said they chronically used NSAIDs were 66 percent more likely to suffer a heart attack over three years, versus patients who never or only occasionally used NSAIDs.

And they were more than twice as likely to die of heart disease.

The findings do not prove that NSAIDs were to blame, said lead researcher Dr. Anthony A. Bavry, an assistant professor of medicine at the University of Florida in Gainesville.

"A limitation is that we did not have information on rheumatoid arthritis or osteoarthritis, which may be the reasons a lot of these patients were taking NSAIDs," Bavry explained in an interview.

That's a problem because chronic inflammatory conditions, like rheumatoid arthritis, have themselves been linked to a higher risk of heart complications.

Still, Bavry said, the findings do strengthen the evidence of an association between NSAID use and heart problems.

They also support existing treatment guidelines, Bavry said.

Since 2007, the American Heart Association (AHA) has advised that people with heart disease or at high risk of it first try acetaminophen or aspirin when they need pain relief.

Similarly, when it comes to treating chronic pain in the elderly -- who, because of age, are at risk of heart problems -- the American Geriatrics Society recommends acetaminophen as the first choice.

In all cases, experts say people at high risk should take the lowest painkiller dose needed to ease symptoms, for the shortest time possible.

"The biggest concern is with chronic, long-term use," Bavry said.

His team's study, reported in the American Journal of Medicine, included 22,576 adults with coronary artery disease -- either a history of heart attack or clogged heart arteries -- plus high blood pressure.

Overall, 4 percent reported chronic NSAID use over three years. Of that group, 4.4 percent suffered a heart attack or stroke, or died of cardiovascular causes, per year.

That compared with a rate of 3.7 percent in the rest of the study group, who either never used NSAIDs (other than aspirin) or used them occasionally.

When the researchers accounted for a number of other factors -- including body weight, smoking and whether patients had diabetes or high cholesterol -- chronic NSAID use was still linked to increased risks of both heart attack and death.

It's not clear whether any particular NSAID was riskier than another, according to Bavry's team.

A small subgroup of patients named their NSAID of choice, and it was most often ibuprofen or naproxen. But there was too little information to pin down the potential effects of any single NSAID.

Past studies have suggested that among the NSAIDs, naproxen may be safest for the heart, according to the AHA guidelines. But researchers are still studying the potential heart-health effects of different NSAIDs.

For now, Bavry advised that the elderly and people with heart disease be aware that even over-the-counter painkillers come with safety concerns.

"They should talk with their doctors about what would be the best medications to have on their shelf," he said.

If NSAIDs do directly contribute to heart problems in some people, it's not yet clear why, according to Bavry.

One possibility, he said, is that some NSAIDs, when taken with aspirin, interfere with the latter's heart benefits. Ibuprofen, in particular, has been linked with that effect.

The study was partly funded by Abbott Laboratories, which makes several brands of ibuprofen. Some of Bavry's co-researchers have received funding from various drug companies.